Lenalidomide for Granulomatous Slack Skin

Phase-Based Estimates
1
Effectiveness
1
Safety
Memorial Sloan-Kettering Cancer Center, New York, NY
Granulomatous Slack Skin+14 More
Lenalidomide - Drug
Eligibility
18+
All Sexes
Eligible conditions
Granulomatous Slack Skin

Study Summary

This study is evaluating whether a combination of two drugs may help treat patients with a type of lymphoma.

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Eligible Conditions

  • Granulomatous Slack Skin
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell
  • Mycosis Fungoides
  • Lymphoma
  • Lymphoma, Diffuse
  • Sezary Syndrome
  • Lymphoma, T-Cell, Peripheral
  • Mycoses
  • Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides
  • Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified
  • Folliculotropic Mycosis Fungoides
  • Recurrent Mature T- Cell and NK-Cell Non-Hodgkin Lymphoma
  • Lymphoma, Non-Hodgkin
  • refractory, advanced Mycosis fungoides
  • Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Lenalidomide will improve 10 primary outcomes, 1 secondary outcome, and 1 other outcome in patients with Granulomatous Slack Skin. Measurement will happen over the course of Up to 84 days.

Month 12
Changes in biomarkers
Pruritus assessment
Month 12
Time to response
Month 12
Progression free survival
Month 12
Duration of complete response
Month 12
Overall survival
Month 12
Event-free survival
Month 12
Response duration
Up to 12 months
CTCL specific response assessed by Lugano Classification
ORR defined as proportion of patients with complete response (CR) and partial response (PR)
Up to 84 days
Dose limiting toxicity assessed by CTCAE version 4.03
Day 90
Incidence of adverse events assessed by National Cancer Institute CTCAE version 4.03

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Arm II (durvalumab, lenalidomide)

This trial requires 62 total participants across 2 different treatment groups

This trial involves 2 different treatments. Lenalidomide is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm II (durvalumab, lenalidomide)Patients receive durvalumab IV over 1 hour on day 1 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Arm I (durvalumab)Patients receive durvalumab IV over 1 hour on day 1. Treatment repeats every 28 (+/- 3) days for up to 13 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenalidomide
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

Memorial Sloan-Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Granulomatous Slack Skin or one of the other 14 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Fully recovered from acute toxicities (except alopecia) of all prior therapies to Common Terminology Criteria for Adverse Events (CTCAE) =< grade 1
Failed >= 2 prior systemic therapies *NOTE: For systemic ALCL prior systemic therapy must also include progression on brentuximab vedotin
Stage of disease according to TNMB classification
Pathology report must be diagnostic or be consistent with MF/SS criteria
Documented informed consent of the participant and/or legally authorized representative
Registered into Revlimid REMS program
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Relapsed/refractory disease
CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY
Histologically confirmed mycosis fungoides (MF) or Sezary syndrome (SS); Phase 1: >= stage IIB OR >= stage IB-IIA folliculotropic/transformed MF; Phase 2: >= stage IB

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes granulomatous slack skin?

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Granulomatous slack skin is a clinically stable disease, but the only known risk factor is having a sibling with the disease. Its pathophysiology, however, is not fully known, and this disease may not be a unique disease entity.

Unverified Answer

What is granulomatous slack skin?

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Granulomatous slack skin is the term for a newly established classification of sarcoid lesions and is distinguished by its characteristic nonaggressive histopathology, benign clinical course, and a lack of immunosuppressive treatments in patients with systemic involvement. Other terms often used for this disease are granuloma-slack sarcoma syndrome and granulomatous sarcoidosis. It can be seen in patients of all ages and in Caucasians, East Africans, Asians, and Hispanics. There is growing interest in granulomatous slack skin and other sarcoid conditions worldwide since sarcoidosis cases have become more prevalent with time.

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What are the signs of granulomatous slack skin?

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Granulomatous slack skin is an infrequent, chronic dermatosis with a wide variety of clinical and histopathologic findings. The classic form of granulomatous slack skin consists of non-scarring, non-inflammatory, erythematous papules, typically with a roughened texture. Small nodules, vesiculobullous scars, or fibrosis are also found. Granulomatous slack skin may also present with more severe, non-scarring, inflammatory lesions, such as erythema nodosum, which has a smoother, non-roughened appearance.

Unverified Answer

How many people get granulomatous slack skin a year in the United States?

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Granulomatous slack skin affects 0.6 to 1.0% of people in the US. The prevalence among adults was about 12.3 per 100,000. These values will be higher among the elderly and people of African descent. Granulomatous slack skin is more common in men than in women.

Unverified Answer

What are common treatments for granulomatous slack skin?

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The main treatments include excision, antibiotics (tetracyclines and sulfa- or tetracyclines plus sulfamethoxazole), and/or antimycotic agents including itraconazole, terbinafine, fluconazole, clotrimazole, micafungin, and/or ketoconazole. Anti-fungal immunotherapy may be used for the prevention of recurrence in some cases of granulomatous skin disease. A Cochrane review from 2011 summarised the evidence and reported that no trials provided sufficient information to permit a meta-analysis.

Unverified Answer

Can granulomatous slack skin be cured?

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Although a full explanation is not available, we suggest that granulomatous slack skin should not be corrected and should be left to the natural progression of disease. Our observations challenge the conventional paradigm of dermatitis herpetiformis, as well as the notion that granulomatous slack skin can be cured through surgical correction and that this is particularly viable when used to treat refractory disease.

Unverified Answer

Is lenalidomide typically used in combination with any other treatments?

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Oral lenalidomide with other treatments was used in an unusually high proportion of patients undergoing treatment, particularly in those who received chemotherapy. In clinical trials, lenalidomide was also used as monotherapy for MDS or PMFL.

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Is lenalidomide safe for people?

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People taking lenalidomide in combination with interferon alpha are at increased risk of developing grade 3 and 4 neutropenia. Grade 3 and 4 neutropenia has not previously been described, with grade 4 neutropenia appearing to be a greater problem. It is possible that people taking lenalidomide may also experience an increased risk of infections.

Unverified Answer

What are the chances of developing granulomatous slack skin?

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These data support a significant risk in subjects with granulomatous slack skin and suggest that the condition is related to a deficiency in the production of interferon.

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Have there been other clinical trials involving lenalidomide?

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Currently there are few studies that report on the efficacy using lenalidomide, thus it is difficult to determine the effectiveness and safety. To find more current evidence, trials in the use of lenalidomide in various conditions will need to be conducted.

Unverified Answer

How quickly does granulomatous slack skin spread?

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The rate of progression of GS skin disease varies greatly depending on the nature of the disease and the patient and can be variable, but generally is around 5 years, or, in an average case, 12 years. The risk of progression seems related to patient demographics and disease progression. Further studies need to be done to determine the factors that may predict the timing of progression.

Unverified Answer

What is the latest research for granulomatous slack skin?

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There is more research on granulomatous slack skin than any other type of granuloma. To get better outcomes for granulomatous slack skin, physicians and scientists need more tools and new information like the effects of treatment drugs, prognosis and treatment responses.

Unverified Answer
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